Search

BackgroundA national serosurvey of U.S. blood donors conducted in partnership with the Centers for Disease Control and Prevention (CDC) was initiated to estimate the prevalence of SARS-CoV-2 infections and vaccinations.MethodsBeginning in July 2020, the Nationwide Blood Donor Seroprevalence Study collaborated with multiple blood collection organizations, testing labs, and leadership from government partners to capture, test, and analyze approximately 150,000 blood donation specimens per month in a repeated, cross-sectional seroprevalence survey.ResultsA CDC website (https://covid.cdc.gov/covid-data-tracker/#nationwide-blood-donor-seroprevalence) provided stratified, population-level results to public health professionals and the general public.DiscussionThe study adapted operations as the pandemic evolved, changing specimen flow and testing algorithms, and collecting additional data elements in response to changing policies on universal blood donation screening and administration of SARS-CoV-2 spike-based vaccines. The national serosurvey demonstrated the utility of serosurveillance testing of residual blood donations and highlighted the role of the blood collection industry in public-private partnerships during a public health emergency.

BackgroundIn 2017, San Francisco's initiative to locally eliminate hepatitis C virus (HCV) as a public health threat, End Hep C SF, generated an estimate of city-wide HCV prevalence in 2015, but only incorporated limited information about population HCV treatment. Using additional data and updated methods, we aimed to update the 2015 estimate to 2019 and provide a more accurate estimate of the number of people with untreated, active HCV infection overall and in key subgroups-people who inject drugs (PWID), men who have sex with men (MSM), and low socioeconomic status transgender women (low SES TW).MethodsOur estimates are based on triangulation of data from blood bank testing records, cross-sectional and longitudinal observational studies, and published literature. We calculated subpopulation estimates based on biological sex, age and/or HCV risk group. When multiple sources of data were available for subpopulation estimates, we calculated an average using inverse variance weighting. Plausible ranges (PRs) were conservatively estimated to convey uncertainty.ResultsThe total number of people estimated to have anti-HCV antibodies in San Francisco in 2019 was 22,585 (PR:12,014-44,152), with a citywide seroprevalence of 2.6% (PR:1.4%-5.0%)-similar to the 2015 estimate of 21,758 (PR:10,274-42,067). Of all people with evidence of past or present infection, an estimated 11,582 (PR:4,864-35,094) still had untreated, active HCV infection, representing 51.3% (PR:40.5%-79.5%) of all people with anti-HCV antibodies, and 1.3% (PR:0.6%-4.0%) of all San Franciscans. PWID comprised an estimated 2.8% of the total population of San Francisco, yet 73.1% of people with anti-HCV antibodies and 90.4% (n = 10,468, PR:4,690-17,628) of untreated, active HCV infections were among PWID. MSM comprised 7.8% of the total population, yet 11.7% of people with anti-HCV antibodies and 1.0% (n = 119, PR:0-423) of those with untreated active infections. Low SES TW comprised an estimated 0.1% of the total population, yet 1.4% of people with HCV antibodies and 1.6% (n = 183, PR:130-252) of people with untreated active infections.ConclusionsDespite the above-average number (2.6%) of people with anti-HCV antibodies, we estimate that only 1.3% (PR:0.6%-4.0%) of all San Francisco residents have untreated, active HCV infection-likely a reflection of San Francisco's robust efforts to diagnose infection among high-risk groups and initiate curative treatment with as many people as possible. While plausible ranges of infections are wide, these findings indicate that while the overall number of people with anti-HCV antibodies may have increased slightly, the number of people with active HCV infection may have decreased slightly since 2015. This estimate improves upon the 2015 calculations by directly estimating the impact of curative treatment citywide and in subgroups. However, more research is needed to better understand the burden of HCV disease among other subgroups at high risk, such as Blacks/African Americans, people with a history of injection drug use (but not injecting drugs in the last 12 months), people who are currently or formerly incarcerated, and people who are currently or formerly unhoused.

BackgroundHuman T-Cell Lymphotropic Viruses (HTLV) type 1 and type 2 account for an estimated 5 to 10 million infections worldwide and are transmitted through breast feeding, sexual contacts and contaminated cellular blood components. HTLV-associated syndromes are considered as neglected diseases for which there are no vaccines or therapies available, making it particularly important to ensure the best possible diagnosis to enable proper counselling of infected persons and avoid secondary transmission. Although high quality antibody screening assays are available, currently available confirmatory tests are costly and have variable performance, with high rates of indeterminate and non-typable results reported in many regions of the world. The objective of this project was to develop and validate a new high-performance multiplex immunoassay for confirmation and discrimination of HTLV-1 and HTLV-2 strains.Methodology/principal findingsThe multiplex platform was used first as a tool to identify suitable antigens and in a second step for assay development. With data generated on over 400 HTLV-positive blood donors sourced from USA and French blood banks, we developed and validated a high-precision interpretation algorithm. The Multi-HTLV assay demonstrated very high performance for confirmation and strain discrimination with 100% sensitivity, 98.1% specificity and 100% of typing accuracy in validation samples. The assay can be interpreted either visually or automatically with a colorimetric image reader and custom algorithm, providing highly reliable results.Conclusions/significanceThe newly developed Multi-HTLV is very competitive with currently used confirmatory assays and reduces considerably the number of indeterminate results. The multiparametric nature of the assay opens new avenues to study specific serological signatures of each patient, follow the evolution of infection, and explore utility for HTLV disease prognosis. Improving HTLV diagnostic testing will be critical to reduce transmission and to improve monitoring of seropositive patients.

BackgroundCharacterisation of the dynamics of Zika virus persistence following acute infection is needed to inform blood donor and diagnostic testing policies and understand the natural history of Zika virus infection. We aimed to characterise the natural history, persistence, and clinical outcomes of Zika virus infection through a prospective study in initially asymptomatic Zika virus RNA-positive blood donors.MethodsZika virus-infected blood donors identified through Zika virus nucleic acid amplification test (NAAT) screening at three blood collection organisations in the USA were enrolled into a 1-year follow-up study, with blood and body fluid samples and detailed symptom data collected at up to seven visits. All samples were tested for Zika virus RNA by real-time PCR (rtPCR); follow-up plasma, whole blood, and urine were also tested by replicate NAAT. Plasma was tested for flavivirus-specific IgM and IgG by ELISA. Zika virus RNA persistence for each assay or sample type and plasma antibody persistence from estimated date of plasma NAAT-detectable infection were calculated from follow-up data using survival statistical methods.FindingsBetween July 6, 2016 and March 7, 2017, we enrolled 53 participants. From the estimated date of plasma NAAT-detectable infection, Zika virus RNA was detectable in plasma for 9·9 days (95% CI 8·1-12·0), in red blood cells for 95·4 days (62·8-129·1), and in whole blood for 73·5 days (39·8-107·5). Replicate NAATs (one or more of eight replicates positive) extended detection of Zika virus RNA in plasma to 34·8 days (19·9-56·2) and in whole blood (at least one of two tests positive) to 104·8 days (76·7-129·9). Urine was rtPCR reactive up to 14·5 days (10·5-20·3) and saliva up to 26·4 days (19·7-38·7). Zika virus IgM persisted for 237·7 days (128·7-459·5) from estimated time since plasma NAAT-detectable infection. Zika virus RNA fell below detectable limits more rapidly in the saliva of participants with pre-existing dengue virus IgG than in those without. Of 25 donors identified pre-seroconversion with symptom data at the first or second study visit, 16 (64%) developed multiple Zika virus-related symptoms after asymptomatic index donations, compared with nine (36%) of 25 donors detected after seroconversion.InterpretationDetermination of viral marker persistence is enhanced by follow-up of blood donors who are pre-symptomatic or asymptomatic, Zika virus RNA-positive, and antibody negative. Zika virus RNA persists in red blood cells for several months following clearance from plasma and body fluids, and replicate, highly sensitive NAATs extend RNA detection in all compartments. Whole blood testing can extend detection of acute infection for diagnostics and monitoring of pregnant women, sexual partners, and travellers.FundingNational Heart, Lung, and Blood Institute, Biomedical Advanced Research and Development Authority.

PurposeOutpatients with hematologic disease often receive red cell transfusion to treat anemia and fatigue. The effect of transfusion on fatigue-related quality of life and how well this effect is sustained has not been quantified. The study aim was to describe the early and sustained impact over 4 weeks of red cells on patient-reported fatigue in outpatients age ≥ 50 receiving transfusion as routine clinical care.MethodsFACIT-Fatigue scale scores were measured pre-transfusion and at visits targeting 3, 7, and 28 days post-transfusion. Group-based trajectory modeling of patient fatigue scores by study day was used to identify the number of distinct trajectories (Groups), then longitudinal mixed effects modeling of fatigue scores was used to estimate group-specific mean improvements early after transfusion and between days 3 and 28 post-transfusion.ResultsFour distinct fatigue score trajectory groups were identified and were found to be correlated with baseline fatigue scores (means 12, 26, 34, and 47 points). In the three groups with the lowest fatigue trajectories (indicating greater fatigue), improvements in fatigue early after transfusion achieved the established minimum clinically important difference (≥ 3 points, Group p = 0.0039). In all trajectory groups, mean fatigue levels did not change significantly between 3 and 28 days (± 1 point, Group p = 0.60).ConclusionPatient-reported fatigue varies widely among older adult outpatients with hematologic disorders. Nonetheless, trajectory modeling suggests that most anemic patients can expect a noticeable improvement in fatigue in the first few days after transfusion that generally is sustained up to 4 weeks.

A 2014 report evaluating accuracy of serologic testing for transfusion-transmissible viruses at African blood center laboratories found sensitivities of 92%, 87%, and 90% for detecting infections with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), respectively (1). Following substantial investments in national blood transfusion service (NBTS) laboratories, in 2017 investigators tested proficiency at 84 blood center laboratories (29 NBTS and 55 non-NBTS) in seven African countries. A blinded panel of 25 plasma samples was shipped to each participating laboratory for testing with their usual protocols based on rapid diagnostic tests (RDTs) (2) and third and fourth generation enzyme immunoassays (EIA-3 and EIA-4). Sensitivity and specificity were estimated using separate regression models that clustered assays by laboratory and adjusted for assay type and NBTS laboratory status. Mean specificities were ≥95% for all three viruses; however, mean sensitivities were 97% for HIV-positive, 76% for HBV-positive, and 80% for HCV-positive samples. Testing sensitivities for all viruses were high when EIA-3 assays were used (≥97%). Lower sensitivities for HBV-positive samples and HCV-positive samples were associated with assay types other than EIA-3, used primarily by non-NBTS laboratories. Proficiency for HIV testing has improved following international investments, but proficiency remains suboptimal for HBV and HCV testing. In sub-Saharan African blood centers, the quality of rapid tests used for HBV and HCV screening needs to be improved or their use discouraged in favor of EIA-3 tests.

BACKGROUND: The way in which the donor history questionnaire is conducted plays a crucial role in the self-disclosure of behavioral risk factors for human immunodeficiency virus (HIV) infection by prospective donors. The South African National Blood Service changed its policy on the process of donor assessment in May 2015 by implementing a compulsory interviewer script used to assess donor eligibility. STUDY DESIGN AND METHODS: A pre- and postevaluation study to determine the impact of scripted interviews on high-risk deferrals and recently acquired HIV infections. We used historical data to compare 18 months before and after the implementation of the script. RESULTS: We recorded a total of 3,169,656 donor presentations during the two 18-months periods, of which 52.2% (1,655,352) were made during the scripted period. A multivariable logistic regression analysis adjusting for donor and demographic characteristics found the odds of high-risk deferral to be slightly greater (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.05-1.07) during the scripted period. A separate multivariate logistic regression model, also adjusting for donor and demographic characteristics, showed that the odds of recently acquired HIV infection were significantly lower (OR, 0.88; 95% CI, 0.79-0.97) during the scripted period. CONCLUSION: This study showed that implementation of a scripted interview was associated with increased HIV risk deferral and decreased recent HIV infection. This study indicates potential improvement in blood safety with the implementation of a scripted donor interview and has relevance to blood safety in other sub-Saharan African countries.

Background and objectivesDonated blood is not currently screened for human T-cell lymphotropic virus (HTLV) in South Africa. Several small studies have detected HTLV-1 in South Africa, but prevalence by geographic region or population group is unavailable.Materials and methodsWe performed a large seroprevalence study of South African blood donors during 3 months in 2013. All geographic regions except the Western Cape were included, and Black and Coloured (local term for mixed race) donors were oversampled. Identity-unlinked plasma samples were screened with the Abbott Prism HTLV-1/2 assay, and repeatedly reactive samples were tested by the Inno-LIA HTLV-1/2 Score confirmatory assay. Odds ratios were calculated with multivariable logistic regression.ResultsOf 46 752 donors tested, 133 (0·28%) were initially reactive, 111 (0·24%) repeatedly reactive and 57 (0·12%) confirmed positive for HTLV-1; none were HTLV-2 positive. Prevalence was 0·062% weighted to annual blood donations but highly concentrated in the Black population group (OR = 20·24 CI: 2·77-147·88); higher in females than males (OR = 1·81 CI: 1·06-3·08); and in donors aged >50 years compared to ages 16-19 (OR = 6·4 CI: 2·95-13·86). After controlling for age, sex and population group, there was no difference in prevalence between new and repeat blood donors or among geographic regions within South Africa.ConclusionsWe conclude that HTLV-1 infection is widespread among the Black population of South Africa and its epidemiology is similar to other endemic areas. Because South Africa is increasing its recruitment of Black blood donors, the implications for blood screening require further consideration.

Background: Studies preceding the COVID‐19 pandemic found that slower time‐to‐return was associated with first‐time, deferred, and mobile drive blood donors. How donor return dynamics changed during the COVID‐19 pandemic is not well understood. Methods: We analyzed visits by whole blood donors from 2017 to 2022 in South Africa (SA) and the United States (US) stratified by mobile and fixed environment, first‐time and repeat donor status, and pre‐COVID19 (before March 2020) and intra‐COVID19. We used Kaplan–Meier curves to characterize time‐to‐return, cumulative incidence functions to analyze switching between donation environments, and Cox proportional hazards models to analyze factors influencing time‐to‐return. Results: Overall time‐to‐return was shorter in SA. Pre‐COVID19, the proportion of donors returning within a year of becoming eligible was lower for deferred donors in both countries regardless of donation environment and deferral type. Intra‐COVID19, the gap between deferred and non‐deferred donors widened in the US but narrowed in SA, where efforts to schedule return visits from deferred donors were intensified, particularly for non‐hemoglobin‐related deferrals. Intra‐COVID19, the proportion of donors returning within a year in SA was higher for deferred first‐time donors (>81%) than for successful first‐time donors (80% at fixed sites; 69% at mobile drives). Conclusions: The pandemic complicated efforts to recruit new donors and schedule returning visits after completed donations. Concerted efforts to improve time‐to‐return for deferred donors helped mitigate donation loss in SA during the public health emergency. [ABSTRACT FROM AUTHOR]

A subset of HIV-infected individuals termed elite controllers (ECs) maintain CD4+ T cell counts and control viral replication in the absence of antiretroviral therapy (ART). Systemic cytokine responses may differentiate ECs from subjects with uncontrolled viral replication or from those who require ART to suppress viral replication. We measured 87 cytokines in four groups of women: 73 ECs, 42 with pharmacologically suppressed viremia (ART), 42 with uncontrolled viral replication (noncontrollers [NCs]), and 48 HIV-uninfected (NEG) subjects. Four cytokines were elevated in ECs but not NCs or ART subjects: CCL14, CCL21, CCL27, and XCL1. In addition, median stromal cell-derived factor-1 (SDF-1) levels were 43% higher in ECs than in NCs. The combination of the five cytokines suppressed R5 and X4 virus replication in resting CD4+ T cells, and individually SDF-1β, CCL14, and CCL27 suppressed R5 virus replication, while SDF-1β, CCL21, and CCL14 suppressed X4 virus replication. Functional studies revealed that the combination of the five cytokines upregulated CD69 and CCR5 and downregulated CXCR4 and CCR7 on CD4+ T cells. The CD69 and CXCR4 effects were driven by SDF-1, while CCL21 downregulated CCR7. The combination of the EC-associated cytokines induced expression of the anti-HIV host restriction factors IFITM1 and IFITM2 and suppressed expression of RNase L and SAMHD1. These results identify a set of cytokines that are elevated in ECs and define their effects on cellular activation, HIV coreceptor expression, and innate restriction factor expression. This cytokine pattern may be a signature characteristic of HIV-1 elite control, potentially important for HIV therapeutic and curative strategies.IMPORTANCE Approximately 1% of people infected with HIV control virus replication without taking antiviral medications. These subjects, termed elite controllers (ECs), are known to have stronger immune responses targeting HIV than the typical HIV-infected subject, but the exact mechanisms of how their immune responses control infection are not known. In this study, we identified five soluble immune signaling molecules (cytokines) in the blood that were higher in ECs than in subjects with typical chronic HIV infection. We demonstrated that these cytokines can activate CD4+ T cells, the target cells for HIV infection. Furthermore, these five EC-associated cytokines could change expression levels of intrinsic resistance factors, or molecules inside the target cell that fight HIV infection. This study is significant in that it identified cytokines elevated in subjects with a good immune response against HIV and defined potential mechanisms as to how these cytokines could induce resistance to the virus in target cells.

Over the past decade, West Nile virus (WNV) has spread across the United States. We aggregated blood donor data from 2010-2012 and then calculated the incidence of WNV RNA-positive donations and compared the incidence with neuroinvasive disease (NID) case data from the ArboNET surveillance system. Of 10,107,853 donations, 640 were confirmed positive. The seasonal WNV incidence rate per 100,000 persons was 33.4 (95% CI 22-45) in 2010, 25.7 (95% CI 15-34) in 2011, and 119.9 (95% CI 98-141) in 2012. NID to blood donor ratios were 1 in 164 (95% CI 152-178) in 2010, 1 in 158 (95% CI 145-174) in 2011, and 1 in 131 (95% CI 127-136) in 2012. We updated estimates of the ratio of NID to WNV infection rates, demonstrating stable disease penetrance over the study period. Blood donor WNV RNA screening is a valuable public health tool for WNV surveillance.

BACKGROUND: West Nile virus (WNV) infection is mostly asymptomatic (AS) but 20% of subjects report WNV fever and 1% of patients experience neurologic diseases with higher rates in elderly and immunosuppressed persons. With no treatment and no vaccine to prevent the development of symptomatic (S) infections, it is essential to understand prognostic factors influencing S disease outcome. Host genetic background has been linked to the development of WNV neuroinvasive disease. This study investigates the association between the ABO and D blood group status and WNV disease outcome. STUDY DESIGN AND METHODS: The distribution of blood groups was investigated within a cohort of 374 WNV+ blood donors including 244 AS and 130 S WNV+ blood donors. Logistic regression analyses were used to examine associations between A, B, O, and D blood groups and WNV clinical disease outcome. RESULTS: S WNV+ donors exhibited increased frequencies of blood group A (S 47.6%, AS 36.8%, p = 0.04; odds ratio [OR], 1.56; 95% confidence interval [CI], 1.01-2.40) and D- individuals (S 21.5%, AS 13.1%, p = 0.03; OR, 1.82; 95% CI, 1.04-3.18). CONCLUSION: The findings suggest a genetic susceptibility placing blood group A and D- individuals at risk for the development of S disease outcome after WNV infection.

BackgroundFalse-positive infectious transfusion screening results remain a challenge with continued loss of both donors and blood products. We sought to identify associations between donor demographic characteristics (age, race, sex, education, first-time donor status) and testing false positive for viruses during routine blood donation screening. In addition the study assessed the prevalence of high-risk behaviors in false-positive donors.Study design and methodsBlood Systems, Inc. donors with allogeneic donations between January 1, 2011, and December 31, 2012, were compared in a case-control study. Those with a false-positive donation for one of four viruses (human immunodeficiency virus [HIV], human T-lymphotropic virus [HTLV], hepatitis B virus [HBV], and hepatitis C virus [HCV]) were included as cases. Those with negative test results were controls. For a subset of cases, infectious risk factors were evaluated.ResultsBlack race and Hispanic ethnicity were associated with HCV and HTLV false-positive results. Male sex and lower education were associated with HCV false positivity, and age 25 to 44 was associated with HTLV false positivity. First-time donors were more likely to be HCV false positive although less likely to be HBV and HTLV false positive. No significant associations between donor demographics and HIV false positivity were observed. A questionnaire for false-positive donors showed low levels of high-risk behaviors.ConclusionDemographic associations with HCV and HTLV false-positive results overlap with those of true infection. While true infection is unlikely given current testing algorithms and risk factor evaluation, the findings suggest nonrandom association. Further investigation into biologic mechanisms is warranted.

BackgroundNo cases of transfusion-transmitted syphilis have been described for over four decades. While there is mandatory transfusion screening for syphilis, the absence of transmission is in part ascribed to a low prevalence of syphilis in the blood donor population, the concomitant use of antibiotics in a high proportion of transfusion recipients, allied with poor survival of T. pallidum during refrigerated storage of blood products.MethodsA cross-sectional retrospective data analysis was conducted to ascertain the prevalence of Treponema pallidum antibodies in U.S. blood donors by demography and geography. Routine blood donation testing data and demographics were extracted from the data warehouse of a large network of U.S. blood centers. Crude and adjusted prevalence of T. pallidum antibodies and active syphilis infection were calculated, and GIS mapping was used to illustrate geographic distribution.ResultsThe prevalence of T. pallidum seropositivity and active syphilis in first time donors was 162.6 (95% CI 145.5-181.2) per 100,000 donors and 15.8 (95% CI 10.8-22.3) per 100,000 donors, respectively. The odds of T. pallidum seropositivity were significantly elevated in African American (OR = 18.9, 95% CI 14.2-25.2), and Hispanic (OR = 2.8, 95% CI 2.0-3.8) as compared to Caucasian donors. Similarly, the odds of active T. pallidum infections were significantly higher in African American (OR 15.0, 95% CI 7.0-32.3) and Hispanic (OR = 5.8, 95% CI 2.9-11.6) as compared to Caucasian donors. Syphilis seropositivity was associated with first time blood donation, increasing age, lower education, birth outside the US, and positive tests for HIV and HCV. Geographically, T. pallidum seropositivity was increased in southern and western regions of the US.ConclusionsGiven the low seroprevalence of syphilis in blood donors, continued screening remains debatable; however it may provide a public health benefit through surveillance of at-risk populations.

BackgroundOther studies have reported high rates of depression and anxiety among human T-lymphotropic virus Type I (HTLV-I)-infected subjects and have even suggested that HTLV-I causes psychiatric disease.Study design and methodsWe interviewed HTLV-I, HTLV-II, and demographically similar HTLV-seronegative blood donors with the Mini-International Neuropsychiatric Interview. Prevalences of major depression and generalized anxiety disorder in each group were calculated and compared to published US population data. Adjusted odds ratios (aOR) and 95% confidence intervals (CIs) controlling for educational achievement, alcohol intake, and self-reported health status were calculated with multivariate logistic regression.ResultsMajor depression was diagnosed in five (5.4%) of 93 HTLV-I-positive subjects (aOR, 2.19; 95% CI, 0.63-7.55) and 17 (6.6%) of 256 HTLV-II-positive subjects (aOR, 1.61; 95% CI, 0.66-3.927), compared to 12 (2.1%) of 585 HTLV-seronegative blood donors. The prevalence of major depression among infected subjects was comparable to the 6.7% prevalence in the US general population. Generalized anxiety disorder was diagnosed in five (5.4%) HTLV-I-positive subjects (OR, 2.32; 95% CI, 0.74-7.26) and 12 (4.7%) HTLV-II-positive subjects (OR, 1.65; 95% CI, 0.68-4.01), compared to 15 (2.6%) seronegative subjects and 3.1% in the US general population.ConclusionMajor depression and generalized anxiety disorder were not significantly more prevalent among HTLV-I- and HTLV-II-infected former blood donors after controlling for health status and other confounding variables. HTLV-seronegative blood donors had lower prevalences of these conditions than the US population, probably due to a "healthy blood donor effect."

We recently discovered the antisense protein of human T-cell leukemia virus (HTLV) type 2 (APH-2), whose messenger RNA is encoded by the antisense strand of the HTLV-2 genome. We quantified proviral load, level of tax, and APH-2 in a series of blood samples obtained from a cohort of HTLV-2 carriers. We determined whether APH-2 promotes cell proliferation. APH-2 was detectable in most samples tested and was correlated with proviral load. APH-2 levels were not correlated with lymphocyte count in vivo, consistent with the inability of APH-2 to promote cell proliferation in vitro. APH-2 does not promote cell proliferation and does not cause lymphocytosis.

BackgroundNucleic acid testing (NAT) is performed on blood collected in the United States allowing for the classification of hepatitis C virus (HCV) antibody-positive donors into resolved and chronic hepatitis C infections. We report a case-control study of factors associated with HCV resolution.Study design and methodsBlood donors with resolved (HCV antibody positive, RNA negative defined as "cases") or chronic (HCV antibody positive, RNA positive defined as "controls") based on their index donation HCV test results were enrolled. Participants completed a risk factor, symptoms, and treatment questionnaire followed by HCV antibody, HCV RNA, and liver biochemical testing.ResultsWe enrolled 100 cases and 202 controls. In a multivariate logistic regression model, significant independent effects for spontaneous viral clearance were observed for African American (inverse; odds ratio [OR], 0.11; 95% confidence interval [CI], 0.01-0.87), autologous blood donation (OR, 4.70; 95% CI, 2.02-10.94), alcohol intake (OR, 2.39; 95% CI, 1.13-5.03), and transfusion before May 1990 (inverse; OR, 0.36; 95% CI, 0.14-0.91). Cases admitting injection drug use had shorter time since first injection than did controls. Forty-nine index RNA positive controls received antiviral therapy and 25 (51%) were RNA negative at enrollment; surprisingly several RNA-negative cases received liver biopsies and/or antiviral treatment.ConclusionsWe document the role donor screening plays in the identification, subsequent medical evaluation, and treatment among individuals who presumably did not know that they were at risk for HCV infection. Additionally, we confirmed race/ethnicity as a determinant of clearance and suggest infectious dose and route of infection may play a role in clearance.

BackgroundHuman T-lymphotropic virus (HTLV)-I and HTLV-II cause chronic human retroviral infections, but few studies have examined the impact of either virus on survival among otherwise healthy individuals. The authors analyzed all-cause and cancer mortality in a prospective cohort of 155 HTLV-I, 387 HTLV-II, and 799 seronegative subjects.MethodsVital status was ascertained using death certificates, the US Social Security Death Index or family report, and causes of death were grouped into 9 categories. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazards models.ResultsAfter a median follow-up of 15.9 years, there were 105 deaths: 22 HTLV-I, 41 HTLV-II, and 42 HTLV-seronegative. Cancer was the predominant cause of death, resulting in 8 HTLV-I, 17 HTLV-II, and 15 HTLV-seronegative deaths. After adjustment for confounding, HTLV-I status was not significantly associated with increased all-cause mortality, though there was a positive trend (HR: 1.6, 95% CI: 0.8 to 3.1). HTLV-II status was strongly associated with increased all-cause (HR: 2.4, 95% CI: 1.4 to 4.4) and cancer mortality (HR: 3.8, 95% CI: 1.6 to 9.2).ConclusionsThe observed associations of HTLV-II with all-cause and cancer mortality could reflect biological effects of HTLV-II infection, residual confounding by socioeconomic status or other factors, or differential access to health care and cancer screening.

Human T-lymphotropic viruses types I and II (HTLV-I and HTLV-II) cause chronic infections of T lymphocytes that may lead to leukemia and myelopathy. However, their long-term effects on blood counts and hematopoiesis are poorly understood. We followed 151 HTLV-I-seropositive, 387 HTLV-II-seropositive, and 799 HTLV-seronegative former blood donors from 5 U.S. blood centers for a median of 14.0 years. Complete blood counts were performed every 2 years. Multivariable repeated measures analyses were conducted to evaluate the independent effect of HTLV infection and potential confounders on 9 hematologic measurements. Participants with HTLV-II had significant (P < .05) increases in their adjusted lymphocyte counts (+126 cells/mm(3); approximately +7%), hemoglobin (+2 g/L [+0.2 g/dL]) and mean corpuscular volume (MCV; 1.0 fL) compared with seronegative participants. Participants with HTLV-I and HTLV-II had higher adjusted platelet counts (+16 544 and +21 657 cells/mm(3); P < .05) than seronegatives. Among all participants, time led to decreases in platelet count and lymphocyte counts, and to increases in MCV and monocytes. Sex, race, smoking, and alcohol consumption all had significant effects on blood counts. The HTLV-II effect on lymphocytes is novel and may be related to viral transactivation or immune response. HTLV-I and HTLV-II associations with higher platelet counts suggest viral effects on hematopoietic growth factors or cytokines.

Hospital-based studies suggest that hepatitis C virus (HCV) infection causes frequent cirrhosis, hepatocellular carcinoma, and mortality, but epidemiologic studies have shown less morbidity and mortality. The authors performed a retrospective cohort study of 10,259 recombinant immunoblot assay-confirmed, HCV antibody-positive (HCV+), allogeneic blood donors from 1991 to 2002 and 10,259 HCV antibody-negative (HCV-) donors matched for year of donation, age, gender, and Zone Improvement Plan Code (ZIP Code). Vital status through 2003 was obtained from the US National Death Index, and hazard ratios with 95% confidence intervals were calculated by survival analysis. After a mean follow-up of 7.7 years, there were 601 (2.92%) deaths: 453 HCV+ and 148 HCV- (hazard ratio (HR) = 3.13, 95% confidence interval (CI): 2.60, 3.76). Excess mortality in the HCV+ group was greatest in liver-related (HR = 45.99, 95% CI: 11.32, 186.74), drug- or alcohol-related (HR = 10.81, 95% CI: 4.68, 24.96), and trauma/suicide (HR = 2.99, 95% CI: 2.05, 4.36) causes. There was also an unexpected increase in cardiovascular mortality among the HCV+ donors (HR = 2.21, 95% CI: 1.41, 3.46). HCV infection is associated with a significant, threefold increase in overall mortality among former blood donors, including significantly increased mortality from liver and cardiovascular causes. High rates of mortality from drug/alcohol and trauma/suicide causes are likely due to lifestyle factors and may be at least partially preventable.

Abstract Background Understanding participation in a prospective study is crucial to maintaining and improving retention rates. In 1990–92, following attempted blood donation at five blood centers, we enrolled 155 HTLV-I, 387 HTLV-II and 799 HTLV seronegative persons in a long-term prospective cohort. Methods Health questionnaires and physical exams were administered at enrollment and 2-year intervals through 2004. To examine factors influencing attendance at study visits of the cohort participants we calculated odds ratios (ORs) with generalized estimated equations (GEE) to analyze fixed and time-varying predictors of study visit participation. Results There were significant independent associations between better visit attendance and female gender (OR = 1.31), graduate education (OR = 1.86) and income > $75,000 (OR = 2.68). Participants at two centers (OR = 0.47, 0.67) and of Black race/ethnicity (OR = 0.61) were less likely to continue. Higher subject reimbursement for interview was associated with better visit attendance (OR = 1.84 for $25 vs. $10). None of the health related variables (HTLV status, perceived health status and referral to specialty diagnostic exam for potential adverse health outcomes) significantly affected participation after controlling for demographic variables. Conclusion Increasing and maintaining participation by minority and lower socioeconomic status participants is an ongoing challenge in the study of chronic disease outcomes. Future studies should include methods to evaluate attrition and retention, in addition to primary study outcomes, including qualitative analysis of reasons for participation or withdrawal.

Background: Predonation donor deferral is used to select donors with presumed lower risk for transfused transmitted infections. The contribution to blood safety from this practice has not been reported previously for Brazil.Study Design and Methods: At four large Brazilian blood centers from September 2010 to March 2011, donors who were deferred due to responses on eligibility questions were invited to provide a blood sample to test for HIV, hepatitis C virus, hepatitis B virus, human T-lymphotropic virus, syphilis, and Trypanosoma cruzi and complete an audio computer-assisted structured interview on risk behaviors.Results: Of 299,848 potential donors during the study period, 66,870 were deferred with 10,453 (15.6%) for high-risk behaviors. Of those, 4860 (46.5%) were consecutively approached and 4013 (82.5%) participated. Disclosed risk behaviors by audio computer-assisted structured interview included 4 or more sexual partners in the past 12 months (15.0% of females [F] and 34.5% of males [M]), unprotected sex (62.0% F and 44.0% M), other high-risk sexual exposure (85.0% F and 73.0% M), being a person who injects drugs (3.0% F and 10.0% M), and test-seeking (17.0% F and 22.0% M). Eleven percent of deferred males reported male-to-male sex. Individuals who reported other high-risk sexual exposure, sexual partner risk, or male-to-male sex had the highest frequency of confirmed HIV: 1.2, 0.7, and 0.7%, respectively. Individuals who reported male-to-male sex, sexual partner risk, test seeking, and unprotected sex had the highest frequency of confirmed syphilis: 3.8, 3.3, 2.4, and 2.0%, respectively.Conclusion: Donor deferral deters donation by individuals with risk behaviors and elevated rates of infectious disease markers. [ABSTRACT FROM AUTHOR]

Background: The frequency of positive test results for transfusion-transmitted infections (TTIs) among blood donors is an important index of safety; thus, appropriate monitoring is critical, particularly when there are changes in policies affecting donor suitability.Study Design and Methods: Testing algorithms from three large blood systems were reviewed and consensus definitions for a surveillance-positive result for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) established. In addition, information on each donation, including donor demographics and location, was collected. Combined data were analyzed to characterize the epidemiology of TTIs by person, place, and time.Results: Data from 14.8 million donations were collected for 2011 to 2012, representing more than 50% of the US blood supply. Surveillance-positive rates per 10,000 donations were as follows: HBV, 0.76; HCV, 2.0; HIV, 0.28; and HTLV 0.34. Rates did not vary between the 2 years, although there was variation within a year. With the exception of HTLV, rates were higher among males, and all rates were higher among first-time donations. Window-period donations (those positive only in nucleic acid tests) were infrequent (HBV, 13; HCV, 60; HIV, 14) during the 2-year period. Frequencies of surveillance-positive results varied by donor age and residence location.Conclusions: We demonstrated that standardized data from multiple major US blood systems can be combined and analyzed for change. However, TTI frequencies are low, impacting their sensitivity to change. Furthermore, observed fluctuations in TTI frequencies may be secondary to changes in blood donor demographics rather than necessarily reflecting the immediate impact of policy modification. [ABSTRACT FROM AUTHOR]